Study Stopped
Strategic decision to discontinue the study based on adjusted clinical development plan. This decision is not based on any safety concerns.
Trial for Treatment Refractory Trigeminal Neuralgia
BHV3000-202: Phase 2: A Double-Blind, Placebo Controlled, Crossover Trial of BHV-3000 (Rimegepant) for Treatment Refractory Trigeminal Neuralgia
2 other identifiers
interventional
65
1 country
20
Brief Summary
The purpose of this study is to evaluate the efficacy of BHV3000 compared to placebo for subjects with treatment refractory Trigeminal Neuralgia as measured by a 2-point or greater reduction in the average Numeric Pain Rating Scale between the two-week treatment phases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2019
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 8, 2019
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 11, 2023
CompletedResults Posted
Study results publicly available
June 10, 2024
CompletedJune 10, 2024
May 1, 2024
3.9 years
April 29, 2019
May 7, 2024
June 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in the Average Daily Pain Score on Numeric Pain Rating Scale (NPRS) at 2 Week Treatment Phase: DBT Phase
NPRS is an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), higher scores represent worse pain. Participants daily recorded their average pain level over a 24-hour period on NPRS. Pain score was the average of the daily 11-point NPRS recorded within each period. Average of pain score on NPRS according to treatment received in first or second treatment period of DBT phase are used for evaluation of the outcome measure.
DBT Phase: Baseline (before dose on Day 1), 2 Weeks Treatment
Secondary Outcomes (9)
Number of Participants With All-Causality Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Study Drug Discontinuation and Treatment Related AEs: DBT Phase
DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
Number of Participants With Any Change From Baseline in Sheehan Suicidality Tracking Scale (S-STS) Scores: DBT Phase
DBT Phase: Baseline, 2 Weeks Treatment
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: DBT Phase
DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities: DBT Phase
DBT Phase: Day 1 of dosing up to last day of dosing (up to 5 weeks)
Change From Baseline in Penn Facial Pain Scale-Revised (Penn-FPS-R) Total Score at 2 Week Treatment Phase: DBT Phase
DBT Phase: Baseline, 2 Weeks Treatment
- +4 more secondary outcomes
Study Arms (2)
BHV3000
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Subjects with a clinical diagnosis of typical or atypical classical trigeminal neuralgia based on the International Classification of Headache Disorders, 3rd edition, beta version.
- Trigeminal neuralgia symptoms for a minimum of 8 weeks prior to randomization visit.
- Neuroimaging to exclude another cause for the neuralgia, other than neurovascular compression.
You may not qualify if:
- Subject has a structural lesion on neuroimaging, other than vascular compression of the trigeminal nerve or nerve root that would explain the neuralgia
- Subject has a clinically evident neurologic deficit on neurologic exam of the cranial nerves
- Subjects with a history of HIV disease
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
- Uncontrolled hypertension (high blood pressure) at screening
- Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption
- Subject has a history or diagnosis of Gilbert's Syndrome or any other active hepatic or biliary disorder
- The subject has a history or current evidence of any significant and/or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
- History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit
- Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
- Hematologic or solid malignancy diagnosis within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer are eligible for the study if they are cancer-free prior to the screening visit in this study.
- Body mass index \>33kg/m²
- History of gallstones or cholecystectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (20)
Gilbert Neurology Partners, PLLC/CCT Research
Gilbert, Arizona, 85297, United States
Center for Neurohealth DBA Kaizen Brain Center
La Jolla, California, 92037, United States
Imaging Clinic at Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
Stanford Hoover Pavilion
Palo Alto, California, 94304, United States
Stanford Neuroscience Health Center- SNHC Pharmacy
Palo Alto, California, 94304, United States
Stanford Neuroscience Health Center
Palo Alto, California, 94304, United States
Stanford University- CAM Building
Stanford, California, 94305, United States
SouthCoast Research Center
Miami, Florida, 33136, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Johns Hopkins Clinical Outpatient Center
Baltimore, Maryland, 21287, United States
Johns Hopkins ICTR Clinical Research Unit (CRU)
Baltimore, Maryland, 21287, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Dent Neurosciences Research Center
Amherst, New York, 14226, United States
Neurological Surgery Practice of Long Island PLCC
Lake Success, New York, 11042, United States
Neurological Surgery
Lake Success, New York, 11042, United States
Premier Cardiolog Consultants
Lake Success, New York, 11042, United States
Premier Cardiolog Consultants
New Hyde Park, New York, 11042, United States
Premier Cardiology Consultants
New Hyde Park, New York, 11042, United States
North Suffolk Neurology, PC
Port Jefferson Station, New York, 11776, United States
Neurology Diagnostics Inc.
Dayton, Ohio, 45459, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 8, 2019
Study Start
June 25, 2019
Primary Completion
May 11, 2023
Study Completion
May 11, 2023
Last Updated
June 10, 2024
Results First Posted
June 10, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.